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BACKGROUND

• Fewer than 15% of patients respond to retreatment with pegylated interferons (PegIFNs)¹
• Preliminary studies suggest that daily dosing of interferon alfacon-1 (CIFN) plus ribavirin (RBV) can achieve improved outcomes²

PURPOSE

• The DIRECT (IRHC-001) trial is designed to study the efficacy and safety of daily interferon alfacon-1 plus RBV in nonresponder patients

TRIAL SUMMARY

• DIRECT is a Phase III, randomized (1:1:1), open-label research study to determine the sustained virological response (SVR) rate of combination therapy of daily interferon alfacon-1 at either
  Dose 1 or Dose 2 plus RBV compared to no treatment in HCV-infected patients who are nonresponders to previous PegIFN-alfa plus RBV therapy

SAMPLE SIZE

• 510 patients
• Approximately 41 sites in the United States
• Patients randomized (1:1:1) to receive:
  • Dose 1 interferon alfacon-I plus RBV daily for 48 weeks

  or

  • Dose 2 interferon alfacon-1 plus RBV daily for 48 weeks

    or

  • No treatment for 24 weeks (may be eligible to be randomized to a roll-over study,
    Dose 1 daily interferon alfacon-1 or Dose 2 daily interferon alfacon-1 plus RBV for 48 weeks)

REFERENCES

1. NIH Consensus Conference, 2002.
2. Kaiser S, et al. High dose induction therapy with consensus interferon and ribavirin for treatment naïve patients with hepatitis C. Hepatology. 2002A;36(4 pt. 2):362.A.